FDA Adverse Event
Injury
Summary report: N
MBT FOOTWEAR
MDR report key: 2546139
·
Received April 18, 2012
Report
- Report Number
- 3009089619-2012-00002
- Event Type
- Injury
- Date Received
- April 18, 2012
- Date of Event
- November 8, 2010
- Manufacturer
- MASAI MARKETING + TRADING AG
- Product Code
- KNP
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
AFTER WEARING THE SHOES FOR 3 WEEKS SHE STARTED HAVING LEG AND FOOT PAIN, THEN LOW BACK AND HIP PAIN. TWO MONTHS LATER SHE WENT TO THE ER AND WAS "TAKEN OFF WORK" AND DIAGNOSED WITH A LUMBAR "COLLAPSED DISC."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MBT FOOTWEAR | ORTHOSES, CORRECTIVE SHOE | KNP | MASAI MARKETING + TRADING AG | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 45 YR | Other |